Looking for guidance and resources? The links and documents below will help you to understand the main processes and guidelines used by the Cornell IRB, as well as external policies, regulations and best practices that might apply to your research using human participants.
Cornell IRB Guidance & Procedures
Start here: if you aren't sure whether your activity is covered under Cornell's Human Research Protection Program, review this Decision Tree.
Policy 1: Determining Whether a Research Activity Needs IRB Review and Approval
Policy 3: Expedited and Full Board Reviews (Initial, Amendment, and Continuing)
Guidance: Oral Histories, Journalism, and Case Studies
Guidance: Revised Common Rule: Cornell IRB Policies and Procedures
Policy 2: Requests for Exemption
Policy 17: Principal Investigator Roles and Responsibilities
Policy 8: Closing a Research Protocol
Policy 4: Reporting Unanticipated/Adverse Events
Policy 5: Managing Noncompliance
Policy 6: Suspensions and Terminations of IRB Protocols
Policy 7: Reporting Unanticipated Problems to Regulatory Agencies and Sponsors
Guidance: NIH Certificates of Confidentiality
Guidance: Clinical Trials
Guidance: Using HIPAA Data for Research
Policy 18: New York State Laws
Guidance: Revised Common Rule: Cornell IRB Policies and Procedures
Guidance: GDPR Research
Policy 9: Recruitment and Payment of Human Research Participants
Policy 10: Informed Consent Options, Processes, and Documentation
Policy 11: Informed Consent - Research Involving Children
Policy 12: Informed Consent - Research Involving Prisoners
Policy 13: Informed Consent - Research Involving Normal, Healthy Participants
Policy 15: Informed Consent - Research Involving Cornell Students
Guidance: Parent/Guardian Permission for Studies Involving Children
Guidance: Oral Consent
External Regulations & Guidance
Here is a list of selected laws, regulations and guidelines concerning the conduct of research with human participants:
The Federal Policy for the Protection of Human Subjects (the “Common Rule”)
Family Educational Rights and Privacy Act (FERPA)
Food and Drug Administration (FDA) 21 CFR Regulations
General Data Protection Regulation (GDPR)
New York State’s Article 24-A: Protection of Human Subjects
New York Civil Rights Law Section 79-l: Confidentiality of records of genetic tests